Sandoz, Inc. (“Sandoz”) entered into the battlefield over patents related to AbbVie’s Humira® (adalimumab). On July 20, 2017,...
BiosimilarsIP.com News section provides updates on current news and events related to biologics and biosimilars.
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By C. Nichole Gifford Comments are off
On July 24, 2017, Samsung Bioepis and Merck & Co., Inc. announced the launch of Renflexis® (infliximab-abda) in the United States. ...
Tagged with: Infliximab, Janssen, Merck, News, Remicade®, Renflexis®, Samsung Bioepsis
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By Aydin Harston Comments are off
The U.S. Senate passed S.934 – FDA Reauthorization Act of 2017 on Thursday, August 3, 2017, by a 94-1 vote after having been passed by...
Tagged with: BPCIA, BSUFA II, FDA, Guidance, Regulatory
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By C. Nichole Gifford Comments are off
Merck & Co., Inc. (“Merck”) announced last week that the FDA has granted tentative approval for its insulin glargine injection...
Tagged with: Diabetes, Follow-on biologic, Insulin glargine, Lantus®, Legal, LUSDUNA™ Nexvue™, Merck, News, Sanofi
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By C. Nichole Gifford Comments are off
Novartis’ First CAR-T Cell Therapy Tisagenlecleucel (CTL019) The FDA’s Oncologic Drug Advisory Committee (“ODAC”) held a public...
Tagged with: Allergan, Amgen, Avastin®, bevacizumab, Biocon, CAR-T, FDA, Genentech, Herceptin®, Mylan, News, Novartis, Regulatory, Roche, Tisagenlecleucel, trastuzumab
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By C. Nichole Gifford Comments are off
Boehringer Ingelheim International GMBH and Boehringer Ingelheim Pharmaceuticals, Inc. (“Boehringer Ingelheim”) have prevailed in two...
Tagged with: AbbVie, adalimumab, Amgen, Boehinger Ingleheim, Coherus, Humira®, Legal, News, PTAB
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By Aydin Harston and Andrew Storaska Comments are off
H.R.2430 – FDA Reauthorization Act of 2017, a bill reauthorizing all of the U.S. Food and Drug Administration (“FDA”) user fee...
Tagged with: BPCIA, BSUFA II, FDA, Guidance, Regulatory
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